Comparison of Postoperative Drain Insertion Versus No Drain Insertion In Total Laparoscopic Hysterectomy

Comparison of Postoperative Drain Insertion Versus No Drain Insertion In Patients Undergone Total Laparoscopic Hysterectomy

This prospective randomized controlled trial was planned to be conducted among total laparoscopic hysterectomies performed at Zeynep Kamil Maternity and Children's Diseases Training and Research Hospital during one year period. The effect of drain insertion during the surgery will be assessed by this clinical trial. Patients will be assigned into two groups as cases and controls. Patients who will a drain inserted will be considered as case group and patients without a drain will be considered as control group. Patients will be evaluated according to their post operative VAS scores, hematocrit levels, their drainage volume and manifestation of an infection after the surgery.

Study Overview

• Status: Unknown
• Conditions: TOTAL ABDOMINAL HYSTERECTOMY
• Intervention / Treatment: Procedure: SURGICAL DRAIN

Detailed Description

This prospective randomized controlled trial was planned to be conducted from February 2020 to February 2021 and included total laparoscopic hysterectomies performed at Zeynep Kamil Maternity and Children's Diseases Training and Research Hospital during the study period.

Surgeries on patients with existing comorbidity, with underlying malignant conditions, patients diagnosed deeply infiltrative endometriosis during surgery and patients who undergo multiple surgeries will be excluded from the study.

Clinical and descriptive data will be collected from both paper and electronic records, including the pain of the patient, the need for analgesia at the 6th-12th and 24th hour during the post-operative period. Visual analog scale (VAS) will be used to track the pain progression of the patients. Intraabdominal bleeding will be determined by measuring the hematocrit levels and drainage volume at postoperative day 1. Patients will also be assessed according to manifesting an infection in both the short term and long term.

Patients who will a drain inserted will be considered as case group and patients without a drain will be considered as control group. Data will be analyzed using the Statistical Package for Social Sciences (SPSS). A Chi-squared test will be used to evaluate the significance of the associations between variables. Continuous variables will be displayed as means and standard deviations. A P value of ≤0.050 will be considered as significant.

This study obtained ethical approval from the Medical Research & Ethics Committee of Zeynep Kamil Maternity and Children's Diseases Training and Research Hospital.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • Recruiting
    • Zeynep Kamil
    • Contact: enis ozkaya, md; Phone Number: 0090 5054742459; Email: enokaya1979@gmail.com
  • Istanbul, Turkey
    • Recruiting
    • Zeynep Kamil Maternity and Children Training and Research Hospital
    • Contact: enis ozkaya, associated professor; Phone Number: 0090 216 334 94 00; Email: istzeynepkeah.hhak@saglik.gov.tr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Female
• age between 40-70
• undergoing surgery for a benign condition
• having an abdominal surgery for the first time

Exclusion Criteria:

• existing comorbidity
• with underlying malignant conditions
• patients diagnosed deeply infiltrative endometriosis during surgery
• patients who undergone multiple surgeries

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: CONTROL GROUP; patients without a drain
Experimental: CASE GROUP; Patients a drain inserted	Procedure: SURGICAL DRAIN; A surgical drain is a tube used to remove blood, abscess and any type of fluid at the site of the place it is inserted

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
analgesia need at the post-operative period	patient need for analgesia during post operative first day	post operative 6. hour
hematocrit levels	patient hematocrit level at post operative day 1	post operative first day
drainage volume	drainage volume at postoperative day	post operative first day
post operative infection	manifesting an post operative infection in short term and long term	post operative first day and post operative 1. week
pain post operative 6.-12. and 24. hour	will be measured using VAS score	pain

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
analgesia need at the post-operative 6. hour	patient need for analgesia	post-operative 6. hour
analgesia need at the post-operative 12. hour	patient need for analgesia	post-operative 12. hour

Collaborators and Investigators

• Sponsor: Zeynep Kamil Maternity and Pediatric Research and Training Hospital

Publications and helpful links

General Publications

• Weston M, Soyer P, Barral M, Dohan A, Pierre S, Rabei R, Garcia-Reyes K, Kohi MP. Role of Interventional Procedures in Obstetrics and Gynecology. Radiol Clin North Am. 2020 Mar;58(2):445-462. doi: 10.1016/j.rcl.2019.11.006.

Helpful Links

• Post-Caesarean Drain Placement - Minor Procedure Leading to Major Complication
• The effect of peritoneal gas drain on postoperative pain in benign gynecologic laparoscopic surgery: a double-blinded randomized controlled trial

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2020
• Primary Completion (Anticipated): November 1, 2020
• Study Completion (Anticipated): February 1, 2021

Study Registration Dates

• First Submitted: February 22, 2020
• First Submitted That Met QC Criteria: February 23, 2020
• First Posted (Actual): February 26, 2020

Study Record Updates

• Last Update Posted (Actual): February 26, 2020
• Last Update Submitted That Met QC Criteria: February 23, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: visual analog scale; hematocrit; surgical drain
• Other Study ID Numbers: ZEYNEPKAMILHOSPITAL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No